Medical device registration in the Philippines

All medical devices, whether manufactured domestically in the Philippines or imported, must be registered with the Food and Drug Administration’s (FDA) Center for Device Regulation, Radiation, Health and Research (CDRRHR). Registrations of Class A medical devices are currently being processed via an online medical device registration system called “e-notification portal system” while the registration of Class B, C, D and IVD medical devices are submitted and processed via electronic mail.

Who can register a medical device in the Philippines?

In order to register a medical device in the Philippines, a company must first obtain a License to Operate (LTO) as a Medical Device Manufacturer or Distributor (MDDC); Distributor status includes importers, exporters and wholesalers. The LTO can be applied for via the e-portal system and once approved it will be issued by the FDA.

Currently, only local (Filipino) companies can apply for an LTO. Foreign manufacturers, therefore, have three (3) possibilities to register their medical device in the Philippines: 

Set up a legal subsidiary entity

to register the medical devices. Please note that any domestic corporation with more than 40% foreign equity is required to have a minimum capital of US$200,000 and that the establishment process can be complex and time consuming.

Appoint a local distributor

who has an LTO in the Philippines to register the medical devices.

Appoint an independent third party

1a) such as Andaman Medical to register the medical devices. Andaman Medical has a fully certified License to Operate as a Distributor and Importer, and as such acts directly on behalf of foreign manufacturers. See below for more on how we can help.

1b) such as Andaman Medical to register medical devices on behalf of a local distributor who has an LTO. This option is useful in case your preferred local distributor does not have an internal regulatory affairs service. See below for more on how we can help.

Once you have chosen your route-to-market and have ensured that the local company has a valid LTO, they may then proceed to register the medical device with the FDA CDRRHR.

As a signatory to the ASEAN Medical Device Directive (AMDD), the Philippines requires medical device registration submissions to use the ASEAN Common Submission Dossier Template (CSDT) for Class B, C & D devices. The CSDT must be submitted online via electronic mail. Class A medical devices are required to undergo e-notification via the e-notification portal system.

Once the medical device has been either notified or registered according to its class, the FDA CDRRHR will issue a Certificate of Medical Device Notification (CMDN), a Certificate of Medical Device Registration (CMDR) or a Certificate of Product Registration (CPR) which serves as the Marketing Authorization or Product Approval License.

The company which receives the CMDN/CMDR/CPR or Product Approval License is also known as the Product License Holder. Multiple registrations of medical devices with different distributor license holders are allowed in the Philippines if the agreement between the manufacturer/supplier and the distributor (importer/exporter/wholesaler) is non-exclusive. Change of ownership or transfer of the Product Approval License is allowed from one distributor license holder to another once the contract/deed of assignment is terminated, an agreement between the manufacturer and the new importer/distributor is in place and the original copy of Product Approval License is given to the new distributor license holder. For manufacturers, this can prove difficult and costly to obtain, should the existing product license holder not wish to relinquish their right to distribute the product in the Philippines. Hence the advantage of appointing an independent third party as the Product License Holder.

Definition and classification of medical devices in the Philippines

Medical device means any instrument, apparatus, implement, machines, appliance, implants in vitro reagent and calibrator, software, material or other similar related article intended by the manufacturer/product owner to be used, alone or in combination for human being for one or more of the specific purpose(s) of:

Medical devices in the Philippines are classified in terms of risk in accordance with the AMDD, which lists 4 classes:

Class A

Low Risk

Class B

Low to Moderate Risk

Class C

Moderate to High Risk

Class D

High Risk

 

The medical device risk class determines the necessary documentary requirements for registration. The higher the class of medical device, the more documentary information is required for submission in order to register.

In Vitro Diagnostic (IVD) Medical Devices are classified as registrable and non-registrable. Currently, there are only 8 IVD Medical Devices that are considered registrable which are as follows:

Medical device grouping in the Philippines

Currently, there is no “product grouping” available in the Philippines. An application must be made separately for each specific medical device. In case of the following conditions, one application can be filed; however, separate certificates of product registrations shall be issued:

1.

A medical device with accessories wherein the accessories are intended to be sold separately.

2.

A medical device, owned by the same legal manufacturer, that is manufactured in different manufacturing plants and will be distributed at the same time in the Filipino market.

3.

A medical device system where the use of one part of the system is needed to be used together with all or any part of the system.

4.

A medical device with the same intended use and the same manufacturing process but differ in one or more raw materials.

5.

A medical device with the same intended use and the same manufacturing process but differ in the design

6.

6. A medical device with the same raw materials but differ in types or shapes resulting in different specific intended use.

The registration process

Class A medical devices must be submitted online via the e-notification portal system while Class B, C, D and IVD medical devices are submitted via electronic email. The filing of applications for medical device product registrations shall follow the guidelines stated in FDA Circular 2020-026 (this circular was issued in light of the COVID-19 pandemic; amendments are expected as the situation progresses).

For Class A medical devices, once the required fields are filled out and necessary documentation has been uploaded in the e-notification portal, an order of payment will be generated. The registrant has only 5 working days to process payment. For Class B, C, D and IVD medical devices, once the registrant receives an acknowledgment receipt via email, payment should be made, and proof of payment must be emailed so that the application will be formally accepted and considered as successfully filed. Each distributor license holder has a maximum number of submissions that can be made based on the following schedule.

What documents are required to register medical devices in the Philippines?

Various documentation is required to register a medical device in the Philippines and the list differs for in-vitro diagnostics. The language accepted for submission is English.  In general, you will be required to submit a device description, any pre-clinical studies, device labelling, instructions for use, a risk analysis and of course any existing regulatory approvals or market authorisations already obtained and manufacturer’s compliance for ISO 13485.

Certain medical devices require separate FDA permits or registrations from other government agencies such as those which contain or transmit radiation and those with wireless connectivity. And some specific products must undergo local testing in an accredited laboratory in the Philippines.

Medical Device Classification Schedule of submission Max no of submission
Class A Daily No limit
Class B, C, D, IVD • On Thursdays for company names starting with numbers and letters A-M
• On Fridays for company names starting with letters N-Z
5 initial or renewal applications & 2 variation or change notifications per company per nominated day

As mentioned, once payment is made, the FDA CDRRHR will formally accept the application for their evaluation process. Should all documentation meet the requirements, the FDA CDRRHR will issue the CMDN/CMDR/CPR or Product Approval License otherwise known as the marketing authorization. However, the FDA CDRRHR may consider that the documentation submitted does not meet the requirements and thereby request additional documentation. At this stage, the FDA CDRRHR will evaluate the submission again, and if successful a marketing authorization will be issued or if not, then the submission will be rejected.

Typical fees and timelines

A fee is payable for each new medical device registration, renewal or variation or change notification. This is a non-tax fee.

Typically, new medical device registrations could take anything between 6 (six) to 9 (nine) months. Should any additional documentation be required to be submitted, then the FDA CDRRHR will allow 30 calendar days to submit the additional data. The FDA CDRRHR will process the evaluation of compliance within a period of about 3 months taking the total timeline to potentially 9-12 months. There is no fee for submitting extra documents. For registration renewals the general timeline is 3-6 months.

For Medical Device and IVD new registrations

Class Fee (inclusive of 1% Legal Research Fund fee) Timeline
CMDN (Class A) PHP 7,575 1-2 months
CMDR (Class B, C, and D) PHP 7,575 6-9 months
CPR (IVD) PHP 1515* 6-9 month**

* Does not include the cost for performance evaluation test. Cost of testing depends on the corresponding National Reference Laboratory (NRL)

** Not including performance evaluation test by NRL (National reference Laboratory)

For Medical Device and IVD renewals

Class Fee (inclusive of 1% LRF fee) Timeline
Class A PHP 5,050 1-2 months
Class B, C and D PHP 5,050 3-6 months
IVD PHP 5,050* 3-6 months**

* Does not include the cost for performance evaluation test. Cost of testing depends on the corresponding National Reference Laboratory (NRL)

** Not including performance evaluation test by NRL (National reference Laboratory)

For Medical Device and IVD variation/change notification

Class Fee per product/change (inclusive of 1% LRF fee) Timeline
Class A PHP 510 1-2 months
Class B, C and D PHP 510 1-2 months
IVD PHP 510 1-2 months

How Andaman Medical can help:

Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.

Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Obtain a quote to register medical devices in the Philippines

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